Why does a significant percentage of all warning letters for medical devices and pharmaceuticals continue to be CAPA-related even though critical thinking and problem solving methodologies proliferate in the industry? In November 2009, the Global Harmonization Task Force (GHTF) issued a draft, proposed guidance document that provides the latest thinking and approach of the regulatory bodies on CAPA. This includes the use of risk-based processes and decisions.

This audio conference discusses how to use risk-based decisions in implementing, prioritizing and conducting CAPA projects and processes. In addition it provides organizational best practices to enable effective CAPA systems.

This audio conference covers:

• The significance of CAPA across an organization’s entire Quality System
• What makes an effective risk-based CAPA system?
• Elements of the new GHTF guidance document
• How should risk be incorporated into the entire CAPA process?
• What are some of the barriers to an effective risk-based CAPA process?
• Best practices that lead to an effective CAPA system

About the speaker:

Dr. Vinny Sastri is the president of WINOVIA® LLC, a company that provides customized solutions, strategies, and implementation of effective product life cycle management and quality management processes. Areas of expertise include product design and development, design controls, process validation, FDA and ISO quality systems for medical devices and pharmaceuticals, manufacturing, risk management, CAPA, and plastics and materials.

He is a certified Six Sigma black belt and is also on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training on the FDA Quality Systems Regulation and Industry Practice to the medical device industry. Dr. Sastri’s book “Plastics in Medical Devices: Properties, Requirements and Applications” was released on April 1st, 2010 by Elsevier, London.

Who should attend?

• Manufacturing Managers and Engineers
• Complaints and Customer Service Personnel
• Installation and Service Personnel
• Supplier Quality Engineers and Managers
• Quality Managers and Engineers
• Regulatory Managers
• Purchasing Managers
• R&D
• Validation Engineers
• Auditors